Coronavirus Update - 09th November 2020

We would like to reassure our customers that as England enters its second national lockdown period, we remain open for business and at full capacity as we have done since the start of this pandemic and fully comply with all government guidance on minimising the risks of COVID-19.

As the situation continues to evolve, we will keep all our customers and stakeholders informed of our activities through this web-page which is updated on a regular basis.

Our work and case studies

Challenge:

Accelerate first-in-human and Phase II trials for an oral dosage form intended for treatment of CNS disorders. A fully integrated approach was required, to include drug substance manufacture, formulation development, GMP clinical manufacture, IMP packaging, labelling and assembly, distribution, and compilation of a CMC dossier.

Customer:

Small biotech (Europe)

Outcome:

A fully integrated pharmaceutical development package, involving all disciplines to include API manufacture, formulation development, product manufacture, analytical method development/validation, QC/QA release, and CMC regulatory document compilation, was successfully delivered to satisfy aggressive timelines. Phase I and multi-centre Phase II studies were completed with confirmation of proof-of-concept, and ownership of the drug substance transferred to a large pharmaceutical company with continued support from Arcinova. 

API Manufacture, Formulation Development, Capsule Product Manufacture Case Study